GSK and Medicines for Malaria Venture (MMV) submitted a new drug application (NDA) to the U.S. FDA, seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. If approved, GSK says tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years, potentially addressing the need for a single-dose and effective medicine for this debilitating disease.
The submission follows the decision made by FDA in December 2013 to grant tafenoquine Breakthrough Therapy Designation, an initiative aimed at expediting the development and review times of drugs for serious or life-threatening conditions.
Pauline Williams, Head of Global Health R&D, GSK said: “This regulatory filing marks a significant and historical milestone in our global health efforts. Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver resulting in relapses. Poor compliance to primaquine in real-world settings can lead to higher relapse rates than those seen in the controlled setting of clinical trials, so a single dose treatment is an attractive proposition...”
Tafenoquine is not approved for use anywhere in the world. GSK plans to progress regulatory filings in other countries in 2017 and 2018.